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Imaging Agent Dangers Being Monitored by FDA

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Lauren Lopez4 years ago

The FDA has placed a cardiovascular imaging agent, known as regadenson (Lexiscan), on a quarterly list of products that are to be monitored.  The agent has appeared on this list due to potential symptoms of the condition myocardial infarction, or MI, and even death.

About the Imaging Agent

Regadenoson is an adenosine-receptor agonist. It produces vasodilation in coronary arteries and is used for radionuclide myocardial perfusion imaging in individuals who do not have the ability to endure, for medical or other reasons, exercise stress testing. The agent is also used for CT imaging.

According to MedScape, the FDA received reports possibly linking Regadenoson was approved by the FDA in 2008 and included warning of a risk for MI and ventricular arrhythmias. In 2011 the drug made the list for signals of QT, and during the second quarter of 2013, the FDA began receiving reports through the FDA Adverse Event Reporting System of cases of MI and death.

Adverse Events Tied to the Imaging Agent

Infomration provided by

  • Nausea
  • Vomiting
  • Loss of consciousness
  • Unresponsiveness to stimuli
  • Hypotension
  • Cardiac Arrest
  • Death
FDA and Watch Listing

Though a drug or product is placed on the FDA watch list, the agency has not conclusively determined whether or not the drug or product poses the reported risks. Instead, the agency further investigates the need to confirm the relationship between the symptoms and the drug or product. The FDA also highlights that a drug or product being on the watch list is not reason for a medical professional to cease using or prescribing.

Contact an Experienced Product Liability Attorney

Thomas J. Henry are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. The Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/ or defective pharmaceuticals.

If you or a loved one have been injured by or have developed serious side-effects from the use of defective medications or pharmaceuticals, contact Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.


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